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Efficacy of Olmesartan in the Treatment of Bevacizumab-associated Hypertension: a Prospective, randomized, Double-blinded, Multi-centre Clinical Trial

Efficacy of Olmesartan in the Treatment of Bevacizumab-associated Hypertension: a Prospective, randomized, Double-blinded, Multi-centre Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020093
Enrollment
Unknown
Registered
2018-12-14
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hypertension

Interventions

Therapy group 1:Prophylactic antihypertensive therapy one week earlier
Therapy group 2:Chemotherapy combined with parallel antihypertension therapy at the same time

Sponsors

First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with advanced colorectal cancer (by pathological examination, imaging examination and tumor marker examination, patients with colorectal cancer lesions and already metastases) are planned to receive antitumor treatment with bevacizumab; 2. Patients whose basal blood pressure was less than 150/100mmHg and were more than 110/70mmHg; 3. Patients with ECOG score of less than 3; 4. Patients who were expected to survive for more than 6 months; 5. Male or female patients aged 18-80 years old; 6. For female patients, fertile women must agree to take effective contraceptive measures after taking part in the trial; 7. For male patients, even if surgical sterilization (such as vasectomy or ligation), abstinence or effective barrier contraception, and no sperm donation, must be agreed within the entire period of the study until the last 28 days after the last therapy; 8. During the growth period, female patients must agree to stop breast feeding within 28 days after the use of this product and stop the treatment; 9. Patients understood the purpose and procedure of the test, volunteered to participate in this test and signed a written informed consent; the patient was willing and able to follow the research program and other program requirements.

Exclusion criteria

Exclusion criteria: 1. Patients with hypertension and have not been effectively controlled (change of lifestyle / antihypertensive drugs still more than 150/100mmHg), have been regularly used in patients with antihypertensive drugs (including CCB, ACEI, ARB, beta blockers, diuretics); Patients who have previously had high blood pressure crisis / hypertensive emergencies; 2. Before bevacizumab, patients with proteinuria (24 hours of urine protein more than 1g/24 hours, or urinary conventional urine protein greater than + +); Patients with chronic kidney disease, have reached more than 3 stages of CKD staging; 3. Patients present olmesartan and other ARB contraindications, and inappropriate to use olmesartan and other ARB drugs, and inability to tolerate the olmesartan and other ARB therapies; 4. Patients with poor prognosis and expected survival time less than 6 months; 5. Patients with severe thromboembolism (including life-threatening myocardial infarction, stroke, and arterial / venous thromboembolism) and patients with severe bleeding (including life-threatening gastrointestinal and respiratory bleeding events); Patients with high risk factors of bleeding or bleeding (including severe peripheral vascular lesions) in the last 1 years (including intracranial vascular disease, cirrhosis, portal hypertension, etc.); 6. Patients underwent tumor surgery (including surgery, endoscopic surgery, interventional operation, etc.) less than 4 weeks; 7. In recent 6 months, patients have been used with VEGF inhibitors or tumor chemotherapeutic agents with anti angiogenic effects; 8. Patients with serious and uncontrolled physical and mental disorders (such as schizophrenia, bipolar disorder, depressive disorder, etc.); 9. Patients with poor compliance, can not cooperate with follow-up, can not adhere to medication patients (such as Alzheimer's disease, etc.); 10. Patients with gastrointestinal perforation or may develop into gastrointestinal perforation (such as refractory gastric ulcer and duodenal ulcer); 11. Patients with poor economic conditions can not afford related expenses; 12. Patients with body weight less than 45kg; 13. The researchers evaluated the patients who were not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Blood presure;Ambulatory blood pressure monitoring;Routine urine;Urine protein quantitative;

Secondary

MeasureTime frame
ECOG score;Progression Free Survival;Time to Tumor Progression;All Cause Death;Cardiovascular Death;

Countries

China

Contacts

Public ContactXia Yunlong

First Affiliated Hospital of Dalian Medical University

yunlong_xia@126.com+86 18098875555

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026